Tyvaso

NDA 22387, held by United Therap. Treprostinil.

As of Nov 13, 2026, NDA 22387 (Tyvaso), held by United Therap, was first approved by FDA on Jul 30, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: Jul 30, 2009
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tyvaso is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Mar 31, 2021	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Oct 19, 2017	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 20, 2014	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 30, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Other Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tyvaso0.6MG/ML · solution;inhalation	Treprostinil	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Apr 3, 2026	Supplement 28Labeling · Standard review	Approved	Letter
May 20, 2022	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 31, 2021	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Oct 19, 2017	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 6, 2016	Supplement 14Labeling · Standard review	Approved	Label Letter
Jun 23, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 1, 2014	Supplement 11Labeling · Standard review	Approved	None posted
May 20, 2014	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 30, 2013	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 7, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 8, 2011	Supplement 4Labeling	Approved	Letter Label
Jul 30, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Other Label

Identifiers

Application: NDA 22387
Drugs@FDA: Overview at FDA
Company: United Therap

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters